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MalnutritionNCT04202939

nutritionDay in Nursing Homes Worldwide: An International Audit and Registry on Nutrition and Outcome

An observational study of Malnutrition, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Due to longer life expectancy, age-related changes and problems become more significant. The aging process is associated with loss of function and reduced performance. Age-related physiological changes in the regulation of nutrition intake and in the gastro-intestinal tract lead to deterioration of the nutritional… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Malnutrition
What is being tested?
nutrition
Type of treatment
Pill or oral medicine
How many people
400,000 participants
Where
1 siteAustria
Study dates
Feb 2007to Dec 2025
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study evaluates nursing homes units and their residents who must be 50 years of age or older.

Who may be able to join

  • nursing home resident
  • minimum age: 50
  • present on nursing home unit on nutritionDay

Who cannot join

  • 49 years and under
  • resident refused to participate in nutritionDay

Trial locations and contacts

1 site in 1 country.

Silvia Tarantino, Dr contact

+436805524917

office@nutritionday.org

Austria1 site, 1 recruiting
  • Medical University Vienna

    Vienna, 1090

    Michael J Hiesmayr, MD, MSc, +43140400 ext. 41090, michael.hiesmayr@meduniwien.ac.at

    Michael J Hiesmayr, MD, MSc

    Recruiting

Other trials in Austria

About this study

Official title: nutritionDay in Nursing Homes: An International Audit and Registry on Nutrition and Outcome

Due to longer life expectancy, age-related changes and problems become more significant. The aging process is associated with loss of function and reduced performance. Age-related physiological changes in the regulation of nutrition intake and in the gastro-intestinal tract lead to deterioration of the nutritional status. Deterioration of the health status and of nutritional intake is further associated with chronic malnutrition, impaired quality of life, increased morbidity, mortality and long-term care. In order to ensure optimal nutritional care of nursing home residents and therefore have a lasting positive affect on their quality of life, morbidity and mortality, it is necessary:

  • to collect data on the quality of nutritional care in nursing homes by means of a simple method that requires no specialization in data acquisition,
  • to acquire knowledge on the prevalence of risk factors of malnutrition in nursing home residents in general and on individual nursing units, also in conjunction with the outcome after six months, and to forward the same to the individual nursing units,
  • to allow comparison with other facilities (with similar profile) with the help of a benchmarking system,
  • to assess the effectiveness of introduced changes in terms of quality management and quality improvement.
Read the detailed description

The study is a population-based, observational cross-section examination carried out on one day, and an outcome evaluation six months later. The examination should be repeated annually. Data is collected with the help of questionnaires. Anonymised data entry into the audit database is done with individual and anonymous center and unit-codes.

There are 2 questionnaires to complete on nutritionDay. The unit staff completes 1 questionnaire about structure of the unit and 1 questionnaire about resident characteristics.

  1. unit sheet: asks for nutrition related organisational and structural information on the unit.
  2. resident description: asks for general characteristics, diseases, care level, mobility and restrictions on food intake.

Outcome Evaluation: re-assesses the resident's outcome 6 months after nutritionDay (residence after 6 months, actual weight, and hospitalization). This questionnaire has to be completed 6 months after nutritionDay by the unit staff.

Participation rules:

  1. A user needs to register to nutritionDay as a member to the nutritionDay network. Each may choose a personal user name. Each user needs to provide a valid email address. After responding to a validation email the user is registered with the chosen user name. User details are stored on a system that is not connected to the nutritionDay registry at any time. One user may serve as contact for several units and centers.
  2. A user may order codes for participation for one or several centers and units. Access to the registry is only possible with a center code and unit code. These codes are selected from a list of random numbers.

Audit/registry recruitment plan:

Participation to the registry is voluntary. There is actually no participation fee. All necessary information can be obtained from a dedicated website (www.nutritionday.org). Participation can be promoted via international and national scientific societies, universities, health care organisations or governmental agencies as well as via advertisement at international and national congresses. T

Risk and benefit assessment:

The study implies no risk whatsoever for the residents. On some levels participation can even be expected to be beneficial:

  • Direct benefit for residents through increased attention to nutritional problems.
  • Raising awareness of decision-makers brought about by the decision-making process taking place prior to participating in the study and receiving the quality report of the nursing unit or facility.
  • Increase awareness of the staff of nursing homes by participating in the study and the quality report. Pilot results suggest that in terms of the Hawthorne effect, just participation alone has a positive influence on nutrition management on nursing units.
  • Since the project is planned for at least two years, it is possible to repeat the study after one year, to be able to monitor changes which were introduced as a result of the first report.
  • Due to prior announcement on the nursing units, residents and their trustees are made aware of the issue of malnutrition and proper diet management. The nutritionDay in hospitals has shown that in many cases for the first time discussions between staff, patients and relatives on this subject were set in motion.

Documentation of the results of the study, data management and data security

All the necessary data for documentation of the study are entered on the questionnaires. On the study forms the nursing unit is identified by a numerical code, which is allocated after application from the audit facility. The questionnaires only include information on year of birth of the residents and their initials. If requested by the nursing units, to facilitate the evaluation of outcomes. the evaluation can be completed without the initials.

The data are entered online into the database from the facility. The coordination center does not have access at any time to documents that would influence the anonymity of the residents.

The data in the coordination center is checked for credibility prior to further evaluation. In the case of unclear or incomplete data, feedback to the responsible person on the nursing unit takes place and a possible correction of data is made. All data are analyzed anonymously, and the results are made available to each nursing unit so that the identity of the nursing unit, as well as the anonymity of the individual residents is assured.

Communication of Results Following data input of the resident's outcome, each nursing unit (the nutritionDay Project Leader person on the ward nursing unit responsible for organizing the nutritionDay and should be who is clearly identifiable by an e-mail address) receives the results compared to the whole project in the form of a quality report on nutritional intake and influencing factors.

The results of the study are published by the head of the study in a scientific journal and presented at scientific conferences.

Statistical Methods An analysis on survival with the target variable "death in nursing homes within six months" will be carried out. Existing risk factors are to be taken into account as covariant causes. Information on the time of admission to the nursing home and the time of death of the residents will be available.

In addition, the trend of weight development of the surviving residents between the nutritionDay and a half year thereafter will be recorded. The connection between nutritional status and weight on the nutritionDay and the course of weight thereafter of the surviving residents will be analyzed

Conditions
Malnutrition
Being tested
nutrition
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nutritionOther

    Also called nursing home food, oral protein energy supplements, enteral nutrition, parenteral nutrition

    type and amount of food eaten or type of oral nutritional supplements as well as enteral or parenteral nutrition

Study groups in NCT04202939
Study groupRoleWhat they receive
nursing homes residentsall residents present in a nursing home unit on nutritionDay
Receives: Other: nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dependence of nutritional intake on nutritional status and risk factors

    dependence of the outcome of nursing home residents' on their nutrient intake, their current nutritional status and risk factors (state of health, level of care

    Measured: 180 days

Secondary outcomes (1)
  1. Nutrition-related structural parameters

    structural parameters (number and type of unit staff, implementation of regular nutrition screening

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2019
  2. Study startFeb 2007
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
400,000 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04202939
Sponsor's protocol ID
407/2005 (nursing homes)
Status last verified
Feb 2021
First submitted
16 Dec 2019
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Upon submission of a research proposal data anonymised data are shared with researcher. Each proposal is submitted to the supervisory board for approval.

Publications

  • Streicher M, Wirth R, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Dysphagia in Nursing Homes-Results From the NutritionDay Project. J Am Med Dir Assoc. 2018 Feb;19(2):141-147.e2. doi: 10.1016/j.jamda.2017.08.015. Epub 2017 Oct 10.

    PubMed 29030310
  • Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. nutritionDay in Nursing Homes-The Association of Nutritional Intake and Nutritional Interventions With 6-Month Mortality in Malnourished Residents. J Am Med Dir Assoc. 2017 Feb 1;18(2):162-168. doi: 10.1016/j.jamda.2016.08.021. Epub 2016 Oct 11.

    PubMed 27742584
  • Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Who receives oral nutritional supplements in nursing homes? Results from the nutritionDay project. Clin Nutr. 2017 Oct;36(5):1360-1371. doi: 10.1016/j.clnu.2016.09.005. Epub 2016 Sep 17.

    PubMed 27692932
  • Wirth R, Streicher M, Smoliner C, Kolb C, Hiesmayr M, Thiem U, Sieber CC, Volkert D. The impact of weight loss and low BMI on mortality of nursing home residents - Results from the nutritionDay in nursing homes. Clin Nutr. 2016 Aug;35(4):900-6. doi: 10.1016/j.clnu.2015.06.003. Epub 2015 Jun 19.

    PubMed 26143743
  • Valentini L, Schindler K, Schlaffer R, Bucher H, Mouhieddine M, Steininger K, Tripamer J, Handschuh M, Schuh C, Volkert D, Lochs H, Sieber CC, Hiesmayr M. The first nutritionDay in nursing homes: participation may improve malnutrition awareness. Clin Nutr. 2009 Apr;28(2):109-16. doi: 10.1016/j.clnu.2009.01.021. Epub 2009 Mar 5.

    PubMed 19264381

Questions about this trial

What is this clinical trial studying?

An observational study of Malnutrition, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael J Hiesmayr, MD, MSc (+43140400 ext. 74940, michael.hiesmayr@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dependence of nutritional intake on nutritional status and risk factors (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04202939, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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